CHILLI II COOLED ABLATION CATHETER
FDA premarket approval P980003/S015 · decided 2005-05-20
Approval details
- PMA number
- P980003
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CHILLI II COOLED ABLATION CATHETER
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 2005-03-16
- Decision date
- 2005-05-20
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- APPROVAL FOR AN EXTENSION OF THE SHELF LIFE FROM SIX (6) MONTHS TO ON (1) YEAR; AND, PACKAGING CHANGES FOR THE CHILLI II ABLATION CATHETER.
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